Clozapine

Product NDC: 51407-085
11-digit product format: 514070085
Labeler code: 51407
Product ID: 51407-085_cc23653d-da2f-49a0-e053-2995a90ae72b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clozapine
Dosage form: TABLET
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA203807
Marketing category: ANDA
Marketing start: 2015-09-17
Marketing end: 0000-00-00
Substance: CLOZAPINE
Active strength: 25 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51407-085		D	Discontinued by firm		2026-10-15
excluded package	package	51407-085	51407-085-01	D	Discontinued by firm		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51407-085-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51407-085-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51407-085-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51407-085-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51407-085-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51407-085-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51407-085-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51407-085-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51407-085-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51407-085-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51407-085-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51407-085-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A203807-001	CLOZAPINE	CLOZAPINE	25MG	TABLET / ORAL	2015-09-17
A203807-002	CLOZAPINE	CLOZAPINE	100MG	TABLET / ORAL	2015-09-17
A203807-003	CLOZAPINE	CLOZAPINE	50MG	TABLET / ORAL	2017-08-22
A203807-004	CLOZAPINE	CLOZAPINE	200MG	TABLET / ORAL	2017-08-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A203807-001	CLOZAPINE	25MG	TABLET / ORAL	2015-09-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203807-002	CLOZAPINE	100MG	TABLET / ORAL	2015-09-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203807-003	CLOZAPINE	50MG	TABLET / ORAL	2017-08-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203807-004	CLOZAPINE	200MG	TABLET / ORAL	2017-08-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203807-001	CLOZAPINE	25MG	TABLET / ORAL	2015-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203807-002	CLOZAPINE	100MG	TABLET / ORAL	2015-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203807-003	CLOZAPINE	50MG	TABLET / ORAL	2017-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203807-004	CLOZAPINE	200MG	TABLET / ORAL	2017-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203807-001	CLOZAPINE	25MG	TABLET / ORAL	2015-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203807-002	CLOZAPINE	100MG	TABLET / ORAL	2015-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203807-003	CLOZAPINE	50MG	TABLET / ORAL	2017-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203807-004	CLOZAPINE	200MG	TABLET / ORAL	2017-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203807-001	CLOZAPINE	25MG	TABLET / ORAL	2015-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203807-002	CLOZAPINE	100MG	TABLET / ORAL	2015-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203807-003	CLOZAPINE	50MG	TABLET / ORAL	2017-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203807-004	CLOZAPINE	200MG	TABLET / ORAL	2017-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203807-001	CLOZAPINE	25MG	TABLET / ORAL	2015-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203807-002	CLOZAPINE	100MG	TABLET / ORAL	2015-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203807-003	CLOZAPINE	50MG	TABLET / ORAL	2017-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203807-004	CLOZAPINE	200MG	TABLET / ORAL	2017-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203807-001	CLOZAPINE	25MG	TABLET / ORAL	2015-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203807-002	CLOZAPINE	100MG	TABLET / ORAL	2015-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203807-003	CLOZAPINE	50MG	TABLET / ORAL	2017-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203807-004	CLOZAPINE	200MG	TABLET / ORAL	2017-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203807-001	CLOZAPINE	25MG	TABLET / ORAL	2015-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203807-002	CLOZAPINE	100MG	TABLET / ORAL	2015-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203807-003	CLOZAPINE	50MG	TABLET / ORAL	2017-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203807-004	CLOZAPINE	200MG	TABLET / ORAL	2017-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203807-001	CLOZAPINE	25MG	TABLET / ORAL	2015-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203807-002	CLOZAPINE	100MG	TABLET / ORAL	2015-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203807-003	CLOZAPINE	50MG	TABLET / ORAL	2017-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203807-004	CLOZAPINE	200MG	TABLET / ORAL	2017-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203807-001	CLOZAPINE	25MG	TABLET / ORAL	2015-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203807-002	CLOZAPINE	100MG	TABLET / ORAL	2015-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203807-003	CLOZAPINE	50MG	TABLET / ORAL	2017-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203807-004	CLOZAPINE	200MG	TABLET / ORAL	2017-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203807-001	CLOZAPINE	25MG	TABLET / ORAL	2015-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203807-002	CLOZAPINE	100MG	TABLET / ORAL	2015-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203807-003	CLOZAPINE	50MG	TABLET / ORAL	2017-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203807-004	CLOZAPINE	200MG	TABLET / ORAL	2017-08-22	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-14 00:12 UTC	2019-12	A203807-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203807-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203807-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203807-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203807-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203807-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203807-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203807-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203807-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203807-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203807-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203807-004	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A203807-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A203807-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A203807-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A203807-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203807-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A203807-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A203807-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A203807-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203807-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203807-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203807-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203807-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203807-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A203807-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A203807-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A203807-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203807-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A203807-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A203807-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A203807-004	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203807-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203807-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203807-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203807-004	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-085-01	EA - Each	51407-085	fea641ca-e67c-404e-804a-f412b2755e90	1	2021-03-02

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J60AR2IKIC	CLOZAPINE	5786-21-0	CLOZAPINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-085-01	51407008501	100 TABLET in 1 BOTTLE (51407-085-01)	100 tablet	2021-01-21	0000-00-00	No	No	Current